Vice President, Legal – Lead Commercial Counsel

Zenas BioPharma, Inc.; Waltham (MA); On-site; USD 272,000 - 340,000; Full time

Job summary

Zenas BioPharma, Inc. in Waltham, MA seeks a Vice President, Legal – Lead Commercial Counsel to guide the commercial legal function as we prepare for the first U.S. product launch of obexelimab.

You will serve as a strategic partner to Commercial, Medical Affairs, Market Access and Patient Support teams. The ideal candidate has JD with 12+ years in biopharma, deep FDA regulatory knowledge, and strong cross-functional collaboration skills.

Qualifications

• JD required with 12+ years of legal experience in biopharma.
• Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance.
• Experience supporting Commercial, Medical Affairs, Market Access and Patient Support functions.
• Experience reviewing promotional and medical materials as a Legal reviewer.
• Ability to interpret healthcare laws and support product launch planning.

Responsibilities

• Serve as key legal partner to commercial and medical teams.
• Provide practical legal advice on pre-launch activities and launch strategy, including marketing and patient programs.
• Counsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues
• Act as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies
• Training of applicable personnel; Oversee outside counsel; conduct and respond to diligence for financings, business development activities and the like; review external corporate content such as press releases

Skills

FDA rules

Commercial law

Cross-functional partner

Promotional review

Education

Juris Doctor (JD)

Job description

Zenas is a clinical-stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas is advancing two late-stage, potential franchise molecules, obexelimab and orelabrutinib. Obexelimab, Zenas’ lead product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self-administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Orelabrutinib is a potentially best-in-class, highly selective CNS-penetrant, oral, small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to address compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Zenas’ earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcγRIIb monoclonal antibody.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary:

The Vice President, Legal – Lead Commercial Counsel will lead the commercial legal function with primary responsibility to support our expected first U.S. product launch (specifically, our antibody obexelimab for patients living with IgG4-RD, for which a BLA was submitted to FDA in May 2026). This individual serves as a trusted strategic partner and provides practical, timely and business-savvy legal advice to the Commercial (Sales, Marketing, Market Access, Analytics), Medical Affairs and Patient Support functions. This role is the subject matter expert (SME) on U.S. healthcare laws, FDA promotional regulations and industry codes to enable legal and compliant pre-launch, launch and ongoing commercial and medical activities. This role partners with Compliance to ensure that the Company’s U.S. compliance program remains risk-based, fit-for-purpose and aligned with our corporate values, while supporting cross-functional teams through advisory responsibilities, training and policy development. The ideal candidate will combine a strategic and seasoned mindset with “hand’s-on” tactical and operational excellence. In-house biotech experience strongly preferred. This position will report to the Chief Legal Officer and be based in our Waltham, MA headquarters location.

Key Responsibilities:

Commercial & Medical Affairs Legal Lead

• Serve as key legal partner and SME to commercial and medical teams
• Provide practical legal advice on pre-launch activities and launch strategy, including medical (e.g., MSL activities and programs), disease awareness, sales, marketing (brand messaging, activities and campaigns), marketing analytics, patient advocacy programs, advisory boards, incentive compensation for commercial personnel and other business activities
• Counsel market access on pricing, reimbursement, distribution and contracting structures; advise on payer engagement issues including PIE and FDAMA 114; draft and lead the development of market access and patient support agreements; advise patient support team on legal issues related to patient support and hub services
• Act as Legal representative reviewing content and messaging on Promotional Review Committee, Medical Legal Regulatory (Medical) Review Committee, Publications Review Committee, ISR reviews, grants and sponsorships committees and similar bodies
• Training of applicable personnel
• Oversee outside counsel; conduct and respond to diligence for financings, business development activities and the like as needed; and review other external corporate content such as press releases

Compliance Program Support

• Provide thought partnership to Compliance to advise commercial, medical, and advocacy teams on compliance obligations
• Partner with Compliance to evolve the U.S. compliance program consistent with company size and scope and aligned with company values
• Partner with Compliance to coordinate training activities including legal and compliance responsibilities, ethics, policies and procedures
• Support development and enhancement of compliance policies and SOPs related to AKS, FCA, and industry codes

Cross-Functional Legal Support

• Coordinate legal support as a cross-functional partner with business and Legal and Compliance colleagues

Other duties and responsibilities as assigned

Qualifications:

• JD required with 12+ years of relevant legal experience in the biopharmaceutical industry (biotech experience strongly preferred; experience with compliance helpful)
• Deep knowledge of FDA promotional regulations, Anti-Kickback Statute, False Claims Act, OIG guidance, and industry codes, and ability to stay current on evolving trends and enforcement priorities
• Experience providing legal support to Commercial, Medical Affairs, Market Access, and Patient Support functions
• Experience reviewing promotional and medical materials as a Legal reviewer
• Ability to interpret and apply healthcare laws to complex business activities
• Experience supporting product launch planning and cross-functional review committees (experience building for a company’s first U.S. launch is preferred)
• Strong business partnering orientation with ability to balance risk and business goals
• Excellent written and verbal communication skills
• Ability to manage multiple priorities in a fast-paced environment; comfortable working in a demanding start-up culture with evolving processes; flexible and able to adapt to new situations as the business demands

#LI-Hybrid

The position is eligible for a competitive compensation and benefits package.

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $272,000 to $340,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.